The Challenge: Why ECL2 and Q-Pulse? · ECL2 is a true resource. I know I can call and ask them a...
Transcript of The Challenge: Why ECL2 and Q-Pulse? · ECL2 is a true resource. I know I can call and ask them a...
CASE STUDY
Gates Biomanufacturing Facility
ORGANIZATION:
Cellular Therapy / Regenerative Medicine
INDUSTRY:
The Gates Biomanufacturing Facility fi nds the perfect fi t for their Quality Program in ECL2 & Q-Pulse
Background:
The Gates Biomanufacturing Facility part of the University of Colorado, is a brand-new facility
which opened up in April of 2015. The GBF is a campus-wide partnership comprised of the
Gates Center, Anschutz Medical Campus, CU School of Medicine (SOM), University of Colorado
Health, Children’s Hospital Colorado and the Gates Frontiers Fund. It serves UC Denver and the
surrounding area focusing on regenerative medicine and protein Biologics.
Regulated By: FDA
The Challenge:
The staff at the Gates Biomanufacturing Facility knew that the process of implementing
a system to support their quality program would be an intensive undertaking. It would be
important to not only fi nd a highly confi gurable system, but to fi nd a company with the specifi c
expertise in cellular therapy that also were experts in the system selected.
Why ECL2 and Q-Pulse?
Gabriel Orosco the Director of Quality for the Gates Biomanufacturing Facility identifi ed Q-Pulse
as a potential solution, but wanted to work with a U.S. based company for the implementation
and on-going support. ECL2 was the perfect fi t. Having an implementation specialist from ECL2
that had been responsible for quality systems at two different cellular therapy labs gave the
Gates Biomanufacturing Facility a unique advantage in the implementation process.
“The staff at ECL2 go out of their way to make things easy. They are active participants in the
consultation, providing multiple solutions for critical scenarios. It’s through this that you can
tell that they have been in your shoes, doing what you need to be doing.” According to Gabe.
Gabe continued on to say, “ECL2’s depth of knowledge in the regenerative medicine space
as well as the elegance and power associated with the Q-Pulse application, and were the
deciding factors in making our purchase. Together this combination has been the backbone of
our electronic quality management solution and it has set us apart in multiple vendor audits.”
Q-Pulse, ECL2 Quality Support Program (QSP)
SOLUTION:
The Solution:
ECL2 makes the implementation process a very interactive one to ensure every client gets a
system that fi ts their unique requirements. The process encourages a level of involvement that
creates excitement when the participants begin to see what can be accomplished.
“As a greenfi eld facility the Q-Pulse solution in concert with ECL2’s guidance made the potential
crippling situation of having infi nite choices into a focused activity to realize the platform’s true
potential.”
Looking at where they were and where they are now, Gabe had the following to say: “Things
have improved in that we have an amazing container for our quality management system
to be operated within. The hierarchy and implementation tools are well thought out. The
intelligence of the program will keep an institution from making bad implementation decisions
while providing a level of fl exibility you do not see with packages running 10 times the cost of
Q-Pulse.”
“Our ECL2 team was professional and friendly. It was painless. ECL2 is a true resource. I know
I can call and ask them a question that they own as a problem they need to solve.” Gabe
concluded by saying, “ECL2 is the defi nition of a hand in glove service.”
For more information on Q-Pulse please visit our website at
www.ECL2.com or contact us directly at 469.828.5006
or by email at [email protected].
www.ECL2.com
Phone: (469) 828-5006
Fax: (972) 355-0594
The staff at ECL2 go out of
their way to make things easy.
They are active participants
in the consultation, providing
multiple solutions for critical
scenarios. It’s through this
that you can tell that they have
been in your shoes, doing
what you need to be doing.
The intelligence of the
program will keep an
institution from making bad
implementation decisions
while providing a level of
fl exibility you do not see with
packages running 10 times the
cost of Q-Pulse.
Gabriel Orosco,Director of Quality
the Gates Biomanufacturing
Facility